Additional update on precautionary recall of chemotherapy products

News Category: Regulatory news

Date: 21/10/2015

The Health Products Regulatory Authority (HPRA) today provides an additional update on the precautionary recall of a number of chemotherapy medicines manufactured by Fannin Compounding Limited (FCL). This recall arose as a test product, which is not administered to patients, showed a contamination some four days after production on 8 October 2015. Evidence of contamination in the test product is not evidence of contamination of the chemotherapy products. Product manufactured on the day of the positive test product is subject to a precautionary recall, along with all other product within a 14 day window (where the daily test product has not completed its 14 day incubation period). The HPRA continues to investigate the incident at FCL which led to this recall and to liaise closely with the HSE on the matter.

Based on the information provided by the company, the HPRA states that as of today, the number of potentially implicated units has reduced to 15. This means that 282 of the original 297 units manufactured in the two week period are deemed clear of risk. This figure includes recalled unused product as well as units that have now passed the incubation period of 14 days for the test product (see also note below).

To date, the HPRA has not received reports of any adverse events associated with these products. Patients who have received the potentially implicated medicines have been contacted by their hospitals as a precautionary measure, informed of the situation and offered a medical appointment.

FCL continues to update each hospital in respect of the status of the specific units they received. This will enable them to confirm those patients who have received a product free from risk of contamination. FCL has confirmed that, in the case of eight public hospitals and four private hospitals/clinics, the units supplied are no longer implicated. The eight public hospitals are: Our Lady of Lourdes Hospital Drogheda, South Tipperary General Hospital, Kerry General Hospital, Beaumont Hospital, Royal Victoria Eye and Ear Hospital, South Infirmary-Victoria Hospital Cork, Naas General Hospital and Portiuncula Hospital.

Background note:
The issue with these products was identified by the manufacturer when carrying out its daily assessments of the manufacturing process using a test product. This test product contains a substance which is used to aid in the detection of the potential presence of contamination. The test product is not a medicine and is not given to patients. On Monday 12 October, a contamination was noted with the test product for one day and the HPRA was notified. A contaminated test product does not automatically mean that the medicines produced are affected.

The test product, which is produced daily, must be incubated for 14 days to identify any contamination and, therefore, as a precaution, all units manufactured from the 29 September were recalled. It is important to note that the equipment (an isolator) in which the medicines were compounded is sanitised daily and the recall of product compounded on the additional days was purely precautionary.

This recall relates only to one isolator and no issues have been identified with other production equipment which is also subject to the same daily test. The isolator concerned has been taken out of use pending completion of the investigation.